摘要
目的探讨GeneXpert MTB/RIF(简称Xpert)法在快速诊断肺结核及检测利福平耐药性中的临床价值。方法收集2018年1月至2019年3月上海市松江区中心医院感染科门诊1059例疑似肺结核患者痰标本,均行Xpert、涂片抗酸染色和结核分枝杆菌液体培养检测。结果1059例疑似肺结核患者中,诊断临床肺结核398例(其中确诊病例297例),非肺结核661例[其中非结核分枝杆菌(NTM)肺病6例]。在疑似病例、临床诊断病例和确诊病例中,Xpert法检测的阳性率分别为21.53%(228/1059)、57.29%(228/398)和71.04%(211/297),均较涂片法[12.09%(128/1059)、30.65%(122/398)和39.39%(117/297)]显著升高(χ^(2)=33.77、57.30、60.16,P值均<0.01),但疑似和临床诊断病例Xpert法阳性率较液体培养法[28.61%(303/1059)、74.62%(297/398)]明显偏低(χ^(2)=14.14、26.64,P值均<0.01)。Xpert法在痰涂片阳性和痰培养阳性患者中的阳性率分别为91.41%(117/128)和69.64%(211/303);确诊病例中,Xpert法对痰涂片阳性患者的诊断符合率为98.29%(115/117),对痰涂片阴性患者的检出率为53.33%(96/180)。以肺结核确诊为金标准,Xpert法和涂片法诊断肺结核的敏感性分别为71.04%(211/297)、39.39%(117/297),特异性分别为97.77%(745/762)、98.56%(751/762);与涂片法相比,Xpert法的敏感性显著升高(χ^(2)=60.16,P<0.01),2种方法的特异性差异无统计学意义。痰涂片阳性、培养阳性而Xpert检测阴性的患者有8例,其中确诊为NTM者6例;以药敏检测利福平耐药作为金标准,Xpert法诊断利福平耐药的敏感性为76.92%(10/13),特异性为98.59%(280/284),阳性预测值为71.43%(10/14),阴性预测值为98.94%(280/283)。结论Xpert在早期诊断肺结核、NTM鉴定和检测利福平耐药等方面具有较好的临床应用价值。
Objective To investigate the clinical value of GeneXpert MTB/RIF(Xpert)in rapid diagnosis of pulmonary tuberculosis and detection of rifampicin-resistance.Methods Sputum specimens of a total of 1059 patients with suspected pulmonary tuberculosis by Xpert assay,smear acid-fast staining and bacterial liquid culture in the Department of Infection,Shanghai Songjiang District Central Hospital from January 2018 to March 2019 were collected.Results Among 1059 patients with suspected pulmonary tuberculosis,398 were diagnosed as clinical pulmonary tuberculosis(including 297 confirmed),and 661 were not pulmonary tuberculosis(including six cases of non-tuberculosis mycobacterium lung disease).In the suspected,clinically diagnosed and confirmed cases,the positive rates detected by Xpert were 21.53%(228/1059),57.29%(228/398)and 71.04%(211/297),respectively,which were significantly higher than those by sputum smear[12.09%(128/1059),30.65%(122/398)and 39.39%(117/297)](χ^(2)=33.77,57.30,60.16,all P<0.01),but the positive rates of Xpert in the suspected and clinically diagnosed cases were significantly lower than those of bacterial culture[28.61%(303/1059),74.62%(297/398)](χ^(2)=14.14,26.64,all P<0.01).The positive rates of Xpert in patients with positive smear or positive culture were 91.41%(117/128)and 69.64%(211/303),respectively.Among the confirmed cases,the diagnostic coincidence rate of Xpert for smear-positive patients was 98.29%(115/117),and the detection rate for smear-negative ones was 53.33%(96/180).Using the confirmed criteria of pulmonary tuberculosis as the"gold standard",the sensitivities of Xpert and smear for diagnosis of pulmonary tuberculosis were 71.04%(211/297)and 39.39%(117/297),and the specificities were 97.77%(745/762)and 98.56%(751/762),respectively.Compared with smear,the sensitivity of Xpert was significantly higher(χ^(2)=60.16,P<0.01),but there was no statistical significance in the specificity.Eight cases with both smear-and culture-positive were negative by Xpert.Among them,six cases were diagnosed as non-tuberculosis mycobacterium.Using rifampicin-resistance of drug sensitivity test as the"gold standard",the sensitivity of Xpert for rifampicin-resistance was 76.92%(10/13),the specificity was 98.59%(280/284),the positive predictive value was 71.43%(10/14),and the negative predictive value was 98.94%(280/283).Conclusions Xpert has good clinical application value in early diagnosis of pulmonary tuberculosis,identification of non-tuberculosis mycobacterium and detection of rifampicin-resistance.
作者
谢平
陈彩萍
白茹
何玉
赵晖
刘纯波
刘亮明
Xie Ping;Chen Caiping;Bai Ru;He Yu;Zhao Hui;Liu Chunbo;Liu Liangming(Department of Infection,Shanghai Songjiang District Central Hospital,Shanghai 201600,China)
出处
《国际呼吸杂志》
2020年第24期1856-1861,共6页
International Journal of Respiration
基金
国家自然科学基金(81770612)。
关键词
结核
肺
痰标本
利福平耐药
临床价值
Tuberculosis,pulmonary
Sputum specimens
Rifampicin-resistance
Clinical value
作者简介
通信作者:刘亮明,Email:liuliangming@hotmail.com。
